RegulationPriority Review (US), Breakthrough Therapy (US), Accelerated Approval (US), Orphan Drug (US), Orphan Drug (EU), Conditional marketing approval (CN)

Structure/Sequence

Molecular FormulaC26H23N7O2

InChIKeyWDENQIQQYWYTPO-IBGZPJMESA-N

CAS Registry1420477-60-6

166

Clinical Trials associated with Acalabrutinib

NCT06520098

/ Not yet recruitingPhase 2IIT

Benefit of Venetoclax Addition ("Benefit VA") in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax.
The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.

Start Date01 Apr 2025

Sponsor / Collaborator

VA Office of Research and Development

NCT06757647

/ Not yet recruitingPhase 2IIT

Prospective Phase 2 Study of the Effect of Acalabrutinib on Myocardium on Ibrutinib Exposed Patients with CLL

This phase II trial tests how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and evaluates how treatment with acalabrutinib affects heart function. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. CLL/SLL patients treated with a different BTK inhibitor called ibrutinib often experience cardiac side effects, leading to discontinuation of life-saving therapy. Treatment with acalabrutinib after discontinuing, or even before starting, treatment with ibrutinib may reverse or prevent cardiac side effects and be an effective treatment option for patients with CLL/SLL.

Start Date01 Mar 2025

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+2]

NCT06651970

/ Not yet recruitingPhase 4

A Multicentre, Open-label, Randomised Phase IV Study to Investigate Acalabrutinib Monotherapy Compared to Investigator's Choice of Treatment in Adults (> 18 Years) With Chronic Lymphocytic Leukaemia and Moderate to Severe Cardiac Impairment

This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally [po], twice daily [bd]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of < 50%.
Randomisation will be stratified by LVEF > 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this study are defined as follows:
Severe cardiac impairment: in those with LVEF ≤ 40% Moderate cardiac impairment: in those with LVEF > 40% to < 50%. The study is planned to take place in approximately 20 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team.
An IDMC will be responsible for making recommendations for study continuation.

Start Date31 Dec 2024

Sponsor / Collaborator

AstraZeneca PLC

[+3]

100 Clinical Results associated with Acalabrutinib

100 Translational Medicine associated with Acalabrutinib

100 Patents (Medical) associated with Acalabrutinib

507

Literatures (Medical) associated with Acalabrutinib

03 Jan 2025·Cancer diagnosis & prognosis

Complete Response (CR) in a Previously-progressing Chronic Lymphocytic Leukemia (CLL) Patient Treated With Methionine Restriction in Combination With First-line Chemotherapy

Article

Author: Han, Qinghong ; Hoffman, Robert M ; Tsuchiya, Hiroyuki ; Demura, Satoru ; Miwa, Shinji ; Kimura, Hiroaki ; Morinaga, Sei ; Kang, Byung Mo ; Higuchi, Takashi ; Mizuta, Kohei ; Igarashi, Kentaro ; Hayashi, Katsuhiro ; Yamamoto, Norio

Background/Aim: Chronic lymphocytic leukemia (CLL) is currently incurable. CLL is characterized by disordered DNA methylation. The aim of the present study was to target methylation with methionine restriction in a patient with progressive CLL. Case Report: Methionine restriction for the patient was achieved with a low-methionine vegan diet and oral recombinant methioninase (o-rMETase). The patient also received rituximab, once per week for four weeks, and acalabrutinib 100 mg, twice daily (bid) continuously. The patient’s white blood cell count decreased by 95% from peak levels and extensive lymphadenopathy disappeared during combination treatment with o-rMETase, rituximab, and acalabrutinib. Conclusion: The combination of methionine restriction and first-line chemotherapy resulted in an apparent complete response (CR) in a CLL patient, a rare event. The duration of the CR will be monitored, and additional CLL patients will be treated similarly in the future.

01 Jan 2025·BMJ Case Reports

Cerebral aspergillosis in a patient with chronic lymphocytic leukaemia complicated by Evans syndrome

Article

Author: Amer, Aly ; Elyas, Mortada

This case report presents a complex medical scenario involving early 60s female patient with a history of chronic lymphocytic leukaemia (CLL) complicated by Evans syndrome, characterised by autoimmune haemolytic anaemia and immune thrombocytopenia. The patient had received various treatments, including steroids, rituximab, cyclosporine and acalabrutinib. The patient’s neurological symptoms began around 3 years prior to presentation, with shaking of her right leg, followed by shaking of both hands, particularly the left hand. She experienced shaking during activities and at rest. Additional symptoms included voice changes, numbness in the feet, dizziness, faintness, fatigue, nausea, vomiting, headaches, walking difficulty, speech changes and back pain. Neurological examination revealed resting tremors, bradykinesia, rigidity and infrequent blinking. An MRI of the brain revealed a 28 mm enhancing intra-axial lesion in the right frontal parietal lobe, accompanied by a 7 mm nodule in the left parietal lobe, both suggestive of neoplastic aetiology. A surgical resection was performed, identifying septate branching fungal hyphae consistent with Aspergillus species, leading to the diagnosis of cerebral aspergillosis. Voriconazole was initiated and subsequently adjusted based on therapeutic drug levels. The patient’s treatment course was complicated by declining platelets, diagnosed as thrombocytopenia, and a positive COVID-19 test result. She received rituximab, immunoglobulin therapy and antifungal treatment adjustments. The patient’s clinical condition improved, including a reduction in tremors and regained mobility. This case underscores the challenges of managing a patient with CLL-associated immune complications, cerebral aspergillosis and a dynamic treatment plan. Clinicians must consider individualised therapeutic strategies and monitor for treatment-related complications in complex cases like this one

01 Jan 2025·HEMATOLOGICAL ONCOLOGY

Molecular Profiling Identifies CD49d and CD79b as Predictive Markers for Acquired Acalabrutinib Resistance in Patients With Chronic Lymphocytic Leukemia

Article

Author: Byrd, John C. ; Mortlock, Andrew ; De Jesus, Gary ; Covey, Todd ; Yamaguchi, Kyoko ; Do, Phuong ; Brown, Jennifer R. ; Parsa, Sara ; Clevenger, Tracy ; Dougherty, Brian ; Munugalavadla, Veerendra ; Whitston, David ; Hartmann, Tanja N. ; Burke, Kathleen ; Floren, Muskan ; Bibikova, Elena ; Furman, Richard R. ; Gulrajani, Michael ; Cheung, Jean ; Frigault, Melanie M. ; Brock, Graham ; Law, Brian

ABSTRACT:

Contemporary studies of Bruton tyrosine kinase inhibitor (BTKi) resistance focus on mutations in the B‐cell receptor (BCR) pathway, but alternative mechanisms of resistance remain undefined. Here, we sought to identify novel predictive markers of acquired resistance to acalabrutinib, a second‐generation BTKi, in patients with chronic lymphocytic leukemia (CLL). Clinical samples from 41 patients with relapsed/refractory or treatment‐naive CLL receiving acalabrutinib as part of a clinical trial (NCT02029443) were divided into two groups: those who continued to respond to treatment (NP, n = 23) and those who developed progressive disease on acalabrutinib therapy (PD, n = 18). Peripheral blood mononuclear cells (PBMCs) from the two groups of patients were profiled at baseline (BL) and at a second timepoint (T2) by RNA‐seq and flow cytometry. Our findings show a correlation between acquired resistance to acalabrutinib and upregulation of integrin alpha‐4 (ITGA4; CD49d), the BCR surface receptor CD79B, and oncogenes such as MYC, LAG3, and MCL1 in CLL cells. High surface expression of CD49d and CD79b prior to acalabrutinib therapy was associated with increased risk of disease progression on acalabrutinib in patients with CLL. When stratified by pretreatment CD49d surface expression, the CD49dhi group (defined as ≥ 30% CD49d+ cells at baseline) showed reduced acalabrutinib‐induced lymphocytosis and higher levels of tumor proliferation markers such as CD38 and Ki‐67 compared with the CD49dlo group (defined as < 30% CD49d+ cells at baseline). In summary, CD49d and CD79b are useful predictive markers for CLL progression on acalabrutinib.Trial Registration:ClinicalTrials.gov identifier: NCT02029443

134

News (Medical) associated with Acalabrutinib

08 Jan 2025

·www.bioinvent.com

BioInvent announces promising initial efficacy data from triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin's lymphoma

The first two patients enrolled in the Phase 2a study triplet arm combining BI-1206 with rituximab and Calquence® responded to treatment One complete response (CR) and one partial response (PR) The treatment has been well-tolerated with no safety or tolerability concerns Study now expanding to additional clinical investigational sites and patient enrollment on track with further Phase 2a results expected by mid-2025 One complete response (CR) and one partial response (PR) The treatment has been well-tolerated with no safety or tolerability concerns Lund, Sweden – January 8, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces promising initial clinical response data from the two enrolled patients in the triple combination arm of the Phase 1/2a study of its anti-FcyRIIB antibody, BI-1206, combined with rituximab and AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor Calquence® (acalabrutinib), in non-Hodgkin's lymphoma (NHL). The preliminary data demonstrates that the combination treatment is well tolerated with the two enrolled patients already showing clinical responses. One patient has obtained a complete response (CR), and one patient shows a partial response (PR). Patient enrollment remains on schedule. Further Phase 2a data are expected by mid-2025. The triplet arm in the Phase 2a study is combining the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm. "It is highly encouraging to see that the move to subcutaneous administration of BI-1206 has led to the improved safety profile we had predicted and hoped for, while also continuing to deliver on the promising efficacy signals already observed. We are also very pleased with the initial data from the Phase 2a triple combination study showing that the first two patients enrolled at the lower dose in the safety run-in are showing responses”. said Martin Welschof, Chief Executive Officer of BioInvent. “The treatment is so far well-tolerated and with increasing interest in the study driven by the triplet arm, we are confident that we can remain on track with enrollment and provide further data next year.” In addition, the Phase 1/2a study of BI-1206 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors continues to progress. The subcutaneous administration of BI-1206 has been well-tolerated with no notable injection reactions. Given the beneficial safety and tolerability profile observed to date, an additional dose cohort with increased dose frequency has been added to the Phase 1 part to further characterize the dose-response/safety of BI-1206 SC in order to maximize the likelihood of success in the subsequent Phase 2a part of the study. The complete response (CR) in solid tumors previously reported in May 2024 at this year's ASCO Annual Meeting for a patient with metastatic melanoma is nearing the two-year milestone, with the response maintained. "With BI-1206, we are continuing to produce compelling clinical data in both non-Hodgkin's lymphoma and solid tumors that demonstrate the potential of targeting FcyRIIB to restore the activity of existing cancer treatments which could lead to life-transforming therapies for patients," said Martin Welschof, Chief Executive Officer of BioInvent. "We look forward to further data from both studies next year and continue to believe that BI-1206 can play an important part in future treatment options for patients with different types of cancers." Calquence® is a registered trademark of the AstraZeneca group of companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About BI-1206BI-1206 is one of BioInvent's lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors. BI-1206 in NHLAll patients in the ongoing Phase 1/2a study (NCT03571568) have previously been treated with one or more rituximab containing treatments. Latest results for the combination of BI-1206 and rituximab were presented in connection with EHA (European Hematology Association) congress in June 2024: the intravenous (IV) Phase 1 part (dose escalation) showcased responses across the dose range of 30-100 mg, including 5 patients with complete response (CR), 1 with partial response (PR) and 6 patients with stable disease (SD) out of 17 evaluable patients. Data from the subcutaneous (SC) Phase 1 part (dose escalation) with BI-1206 + rituximab has showed 2 CR, 3 PR and 3 SD out of 9 evaluable patients. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the triple combination arm of BI-1206 + rituximab + Calquence®. BI-1206 in solid tumorsClinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing. In May 2024, the company announced promising Phase 1 data for BI-1206 in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors. The data showed encouraging and durable responses in patients who previously had failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients. Out of 28 evaluable patients (as of Oct 14th, 2024), the results included one complete response (CR) in metastatic melanoma, one partial response (PR) in uveal melanoma and eight patients with stable disease (SD) as best response, whereof one long-lasting metastatic melanoma patient who had previously progressed on nivolumab treatment that remained a stable disease throughout the two-year study duration. The ongoing study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. Follow us on the social media platform X: @BioInvent. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.comBioInvent International AB (publ)Co. Reg. No. Org nr: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.

Clinical ResultPhase 1Phase 2Immunotherapy

08 Jan 2025

·www.accesswire.com

BioInvent Announces Promising Initial Efficacy Data from Triple Combination Arm of BI-1206, Rituximab and Calquence for the Treatment of non-Hodgkin\'s Lymphoma

LUND, SWEDEN / ACCESSWIRE / January 8, 2025 / BioInvent International (STO:BINV)The first two patients enrolled in the Phase 2a study triplet arm combining BI-1206 with rituximab and Calquence® responded to treatmentOne complete response (CR) and one partial response (PR)The treatment has been well-tolerated with no safety or tolerability concernsStudy now expanding to additional clinical investigational sites and patient enrollment on track with further Phase 2a results expected by mid-2025BioInvent International AB (\"BioInvent\") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announces promising initial clinical response data from the two enrolled patients in the triple combination arm of the Phase 1/2a study of its anti-FcyRIIB antibody, BI-1206, combined with rituximab and AstraZeneca\'s Bruton\'s tyrosine kinase (BTK) inhibitor Calquence® (acalabrutinib), in non-Hodgkin\'s lymphoma (NHL).The preliminary data demonstrates that the combination treatment is well tolerated with the two enrolled patients already showing clinical responses. One patient has obtained a complete response (CR), and one patient shows a partial response (PR). Patient enrollment remains on schedule. Further Phase 2a data are expected by mid-2025.The triplet arm in the Phase 2a study is combining the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib). Approximately 30 patients are expected to be enrolled in Spain, Germany, the US, and Brazil. In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm.\"It is highly encouraging to see that the move to subcutaneous administration of BI-1206 has led to the improved safety profile we had predicted and hoped for, while also continuing to deliver on the promising efficacy signals already observed. We are also very pleased with the initial data from the Phase 2a triple combination study showing that the first two patients enrolled at the lower dose in the safety run-in are showing responses\". said Martin Welschof, Chief Executive Officer of BioInvent . \"The treatment is so far well-tolerated and with increasing interest in the study driven by the triplet arm, we are confident that we can remain on track with enrollment and provide further data next year.\"In addition, the Phase 1/2a study of BI-1206 in combination with MSD\'s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors continues to progress. The subcutaneous administration of BI-1206 has been well-tolerated with no notable injection reactions. Given the beneficial safety and tolerability profile observed to date, an additional dose cohort with increased dose frequency has been added to the Phase 1 part to further characterize the dose-response/safety of BI-1206 SC in order to maximize the likelihood of success in the subsequent Phase 2a part of the study.The complete response (CR) in solid tumors previously reported in May 2024 at this year\'s ASCO Annual Meeting for a patient with metastatic melanoma is nearing the two-year milestone, with the response maintained.\"With BI-1206, we are continuing to produce compelling clinical data in both non-Hodgkin\'s lymphoma and solid tumors that demonstrate the potential of targeting FcyRIIB to restore the activity of existing cancer treatments which could lead to life-transforming therapies for patients,\" said Martin Welschof, Chief Executive Officer of BioInvent. \"We look forward to further data from both studies next year and continue to believe that BI-1206 can play an important part in future treatment options for patients with different types of cancers.\"Calquence® is a registered trademark of the AstraZeneca group of companies. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.About BI-1206BI-1206 is one of BioInvent\'s lead drug candidates and is developed to re-establish the clinical effect of existing cancer treatments such as pembrolizumab and rituximab. The drug candidate is evaluated in two separate clinical programs, one for the treatment of non-Hodgkin\'s lymphoma (NHL, a type of blood cancer) and one for the treatment of solid tumors.BI-1206 in NHLAll patients in the ongoing Phase 1/2a study (NCT03571568) have previously been treated with one or more rituximab containing treatments. Latest results for the combination of BI-1206 and rituximab were presented in connection with EHA (European Hematology Association) congress in June 2024: the intravenous (IV) Phase 1 part (dose escalation) showcased responses across the dose range of 30-100 mg, including 5 patients with complete response (CR), 1 with partial response (PR) and 6 patients with stable disease (SD) out of 17 evaluable patients. Data from the subcutaneous (SC) Phase 1 part (dose escalation) with BI-1206 + rituximab has showed 2 CR, 3 PR and 3 SD out of 9 evaluable patients.In February 2024 BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the triple combination arm of BI-1206 + rituximab + Calquence®.BI-1206 in solid tumorsClinical Phase 1/2a study with BI-1206 in combination with pembrolizumab (NCT04219254) ongoing. In May 2024, the company announced promising Phase 1 data for BI-1206 in combination with MSD\'s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in heavily pre-treated patients with solid tumors. The data showed encouraging and durable responses in patients who previously had failed on anti-PD-1/L1 therapy. The combination was well-tolerated in this heavily pre-treated population of patients. Out of 28 evaluable patients (as of Oct 14th, 2024), the results included one complete response (CR) in metastatic melanoma, one partial response (PR) in uveal melanoma and eight patients with stable disease (SD) as best response, whereof one long-lasting metastatic melanoma patient who had previously progressed on nivolumab treatment that remained a stable disease throughout the two-year study duration. The ongoing study is recruiting patients with advanced solid tumors who had progressed on prior treatments including PD-1/PD-L1 immune checkpoint inhibitors. Patients receive a three-week cycle of BI-1206 in combination with pembrolizumab for up to two years, or until disease progression.About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with currently five drug candidates in six ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company\'s validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company\'s own clinical development pipeline and providing licensing and partnering opportunities.The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company\'s fully integrated manufacturing unit. More information is available at www.bioinvent.com. Follow us on the social media platform X: @BioInvent.For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: [email protected]BioInvent International AB (publ)Co. Reg. No. Org nr: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.comThe press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.This information is information that BioInvent International is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-01-08 08:00 CET.AttachmentsBioInvent announces promising initial efficacy data from triple combination arm of BI-1206, rituximab and Calquence for the treatment of non-Hodgkin\'s lymphomaSOURCE: BioInvent InternationalRelated Documents:

Clinical ResultPhase 1Phase 2Immunotherapy

15 Dec 2024

·www.prnewswire.com

Innovent and Lilly Expand Collaboration Through Agreement on Commercialization Rights for Jaypirca® (pirtobrutinib) in Mainland China

SAN FRANCISCO and SUZHOU, China, Dec. 15, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology and other major diseases, and Eli Lilly and Company (NYSE: LLY) today jointly announced a Distribution and Promotion Agreement in Mainland China regarding Lilly's non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, Jaypirca® (pirtobrutinib, 100 mg & 50 mg tablets). The agreement highlights the following aspects: Innovent will be responsible for the importation, marketing, distribution and promotion of Jaypirca®; Lilly will be responsible for the R&D and post-market medical affairs of Jaypirca®. Jaypirca®, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to re-establish BTK inhibition in mantle cell lymphoma (MCL) patients previously treated with a covalent BTK inhibitor (approved including ibrutinib, acalabrutinib, zanubrutinib, or orelabrutinib) and extend the benefit of targeting the BTK pathway, thus effectively addressing the unmet clinical needs for these patients. Approved by the U.S. FDA in January 2023, Jaypirca® (pirtobrutinib) became the first and only approved non-covalent (reversible) BTK inhibitor. In October 2024, Jaypirca® (pirtobrutinib) received approval from China's National Medical Products Administration (NMPA) as monotherapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two types of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor (Link). Lilly is conducting comprehensive global Phase 3 development programs (including in China), in first-line and relapse or refractory patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and BTK inhibitor-naïve relapse or refractory MCL, to explore monotherapy or combination therapy. Under the agreement, Innovent holds the sole commercialization rights for Jaypirca® in Mainland China, overseeing importation, marketing, distribution and promotion. Lilly will be responsible for R&D and post-market medical affairs. Leveraging Innovent's established hematology oncology commercial team and Lilly's deep expertise in drug development and scientific insights in the therapeutic area, the partnership is committed to broadening access to innovative treatments and improving outcomes for cancer patients in Mainland China. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "Building on our long-term strategic collaboration with Lilly, we are proud to expand our collaboration through this agreement. Jaypirca®, the world's first and only approved non-covalent (reversible) BTK inhibitor, represents a breakthrough treatment option for patients who have previously received BTK inhibitors. Innovent has built a robust and leading portfolio in the hematological malignancy field, consisting of TYVYT® (sintilimab injection), HALPRYZA® (rituximab injection), olverembatinib, FUCASO® (Equecabtagene Autoleucel Injection), and Jaypirca®. By fully leveraging our commercialization capabilities and extensive coverage in this field, we aim to bring forward innovative medicines to benefit cancer patients and further enhance our leading position in oncology. We remain steadfast in our commitment to advancing the biopharmaceutical industry through collaborative efforts so that first-rate pharmaceutical drugs can become widely accessible." Huzur Devletsah, President and General Manager of Lilly China, states, "Lilly is thrilled to appoint Innovent for the distribution and promotion of Jaypirca® marking a pivotal moment in hematologic cancer treatment for Lilly. This agreement allows to rapidly increase patient access in Mainland China by drawing on Innovent's robust market presence and our extensive R&D expertise. Together, we are poised to deliver innovative therapies and support the 'Healthy China 2030' initiative, continuing our commitment: 'In China, For China." About Jaypirca® (pirtobrutinib) Jaypirca® (pirtobrutinib, formerly known as LOXO-305) is a highly selective (300 times more selective for BTK versus 98% of other kinases tested in preclinical studies), non-covalent (reversible) inhibitor of the enzyme BTK.[i] BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including mantle cell lymphoma.[ii],[iii] About Innovent's strategic cooperation with Lilly Innovent and Lilly have established a comprehensive level of cooperation, setting an example of partnership between a Chinese innovative pharmaceutical company and a global leading medicine company in the field of R&D, CMC, clinical development and commercialization, aiming to accelerate the access of innovative medicines to benefit more patients worldwide. In March 2015, Innovent entered into a strategic partnership with Lilly focused on biological medicine. Under the initial agreement, Lilly and Innovent co-developed and co-commercialized oncology medicines, including Tyvyt® (sintilimab injection) in China. In October 2015, the two parties announced the extension of collaboration to include the co-development of three additional antibodies in oncology. In August 2019, the cooperation extended with a licensing agreement for the development and commercialization of a potentially global best-in-class investigational GCG/GLP-1 medicine in China. In August 2020, Innovent and Lilly announced a global expansion of their strategic alliance for sintilimab. In March 2022, Lilly and Innovent deepened their engagement in oncology, granting Innovent sole commercialization rights for Cyramza® (ramucirumab) and Retsevmo® (selpercatinib), and a right of first negotiation for potential future commercialization of Jaypirca® (pirtobrutinib) in Mainland China. In December 2024, the agreement of the commercialization of Jaypirca® (pirtobrutinib) in Mainland China officially achieved. About Innovent Biologics Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 12 products in the market. It has 5 new drug applications under regulatory review, 3 assets in Phase III or pivotal clinical trials and 17 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. Statement: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza), Selpercatinib (Retsevmo) and Pirtobrutinib (Jaypirca) were developed by Eli Lilly and Company. About Eli Lilly and Company Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit . Forward-Looking Statements of Innovent Biologics This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent Biologics, Inc. ("Innovent" or "Company"), are intended to identify certain of such forward-looking statements. The Company does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions. The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. References SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

License out/inDrug ApprovalPhase 3Biosimilar

100 Deals associated with Acalabrutinib

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KEGG	Wiki	ATC	Drug Bank
D10893	Acalabrutinib	L01XE51	DB11703

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Small Lymphocytic Lymphoma	US	AstraZeneca UK Ltd.	21 Nov 2019
Chronic Lymphocytic Leukemia	CA	AstraZeneca Canada, Inc.	02 Oct 2019
Mantle-Cell Lymphoma	US	AstraZeneca UK Ltd.	31 Oct 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Large B-cell lymphoma	Phase 3	DE	AstraZeneca PLC	07 Jun 2023
Recurrent Chronic Lymphoid Leukemia	Phase 3	DE	AstraZeneca PLC	19 Apr 2022
Diffuse Large B-Cell Lymphoma	Phase 3	US	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	CN	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	JP	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	AU	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	AT	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	BE	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	BR	AstraZeneca PLC	08 Oct 2020
Diffuse Large B-Cell Lymphoma	Phase 3	CA	AstraZeneca PLC	08 Oct 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03571568 (Company_Website) Manual	Phase 2	Non-Hodgkin Lymphoma	2	BI-1206 + rituximab + Calquence	honcphiwba(uhhonievgm) = fhtqijokwq zojqwssref (dqvpsmguvt ) View more	Positive	08 Jan 2025
NCT03836261 (AMPLIFY, ASH2024) Manual	Phase 3	Chronic Lymphocytic Leukemia First line	867	Acalabrutinib + Venetoclax	thgvnufkmm(gfackjpmkx) = ndchwfrlgs fydgafnniz (rdjkhqbvbw ) View more	Positive	09 Dec 2024
				Acalabrutinib + Venetoclax + Obinutuzumab	thgvnufkmm(gfackjpmkx) = oipimpdcka fydgafnniz (rdjkhqbvbw ) View more
NCT04462328 (ASH2024) Manual	Phase 1	Primary Central Nervous System Lymphoma	13	Acalabrutinib 100 mg BID + DurvalumabDurvalumab 1500 mg IV	dthgixsnjt(oxketlrmrf) = brtzxcawuq jkdphdcobl (lkjobyghdw ) View more	Positive	09 Dec 2024
ASH2024	Not Applicable	Mantle-Cell Lymphoma	-	Acalabrutinib 100 mg BID + Rituximab 375 mg/m2 IV	jtrruhipzk(ejpfrzybbt) = grade 3-4 AE were cardiovascular toxicity in 7 pts ylyegwcjfl (qggsnliloc ) View more	-	09 Dec 2024
ASH2024	Not Applicable	Mantle-Cell Lymphoma	-	Acalabrutinib	fwsdikpzyu(lezetsgfqi) = 16% ddgrgeqebs (tehvdawtfy ) View more	-	09 Dec 2024
				Venetoclax
ASH2024	Not Applicable	Chronic Lymphocytic Leukemia	-	Acalabrutinib 100 mg	whtrcjvijt(hcftxfypts) = AEs leading to death occurred in 1 pt in the acalabrutinib arm (unrelated to study drug) huyzenlkql (crcbtmlwpt ) View more	-	08 Dec 2024
				Chlorambucil+Rituximab
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	RICE-A + Acalabrutinib 100mg BID	ythwccnqxf(mflweazfvj) = Gastrointestinal AEs were observed in 5 patients (4 Grade1/2 and 1 Grade3/4) jknpgrvzzh (tagjihqtpd ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Chronic Lymphocytic Leukemia	-	Ibrutinib 420 mg/day	bjsgjtokai(wcvngsimkz) = 21% for acala dhlodmpynh (dmfccwcbpg ) View more	-	08 Dec 2024
				Acalabrutinib 100 mg twice daily
ASH2024	Not Applicable	Mantle-Cell Lymphoma	-	Acalabrutinib (BR/CR)	mpnxzypefj(icqfvpyvqw) = ssyohrvvxh bodprvcjtt (iqazyncxwx ) View more	-	07 Dec 2024
				Acalabrutinib (BR/CR-A)	mpnxzypefj(icqfvpyvqw) = obsxzepjvi bodprvcjtt (iqazyncxwx ) View more
ASH2024	Not Applicable	Chronic Lymphocytic Leukemia	-	Acalabrutinib	gmbrhzhfov(vdqstefqek) = crfsnstdph xjitekdevg (sxfurbpogq ) View more	-	07 Dec 2024
				Obinutuzumab	tdodfpiyzl(pmoqsnyirg) = ufuyeqoryi nqprexmnvl (yeupwhcrwl ) View more

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